Skip to content

FXIR4515MS

by Biotem Co., Ltd. South Korea EUDAMED

Ref FXIR4515MS EMDN P01020101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800036220906 Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
FXIR4515MS
Primary DI / UDI-DI
08800036220906
Basic UDI-DI
B-08800036220906
EMDN Code
P01020101 Dental implants
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
KR-MF-000040891
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Biotem Co., ltd

See all devices from Biotem Co., ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 08800036220906|B-08800036220906 61 fields · synced 25 Oct 2026